Acute Stress ReactionASRNCT06390267
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
A study testing Sparrow Hawk (Active) in people with Acute Stress Reaction and Cognitive Performance, run by Spark Biomedical, Inc. at 1 site in United States.
Trial summary
The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor. Read more about this study
- Who is it for?
- Ages 18 to 41 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Reaction, Cognitive Performance
- What is being tested?
- Sparrow Hawk (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18 to 41 years old
- Participant has the cognitive and physical abilities to carry out the study tasks
- Proficient in the English language
- Ability to understand the explanations and instructions given by the study personnel
Who cannot join
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has used any psychological stress-management intervention within the last 4 weeks
- Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
- Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
- Participant is currently using anti-anxiety medications such as Xanax or beta blockers
- Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
Show all 13Show fewer
- History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
- Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation
- Participant has a history of epileptic seizures
- Participant has a history of neurologic diseases or traumatic brain injury
- Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators)
- Females who are pregnant or lactating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.
Read the detailed description
This study is designed as a randomized, double-blind, sham-controlled trial. Sixty healthy, able-bodied participants will be randomized 1:1:2:2 into one of four experimental groups:
Group 1: Active tAN for prophylactic treatment prior to acute stress exposure (N=10)
Group 2: Sham stimulation for prophylactic treatment prior to acute stress exposure (N=10)
Group 3: Active tAN for acute treatment during acute stress exposure (N=20)
Group 4: Sham stimulation for acute treatment during acute stress exposure (N=20)
Participants will complete a baseline performance of three tasks. tAN treatment will then be administered prior to or during an acute stress test. Participants will complete the same three tasks preformed at baseline. In addition to the tAN therapy earpiece, subjects will have biosensors attached to them to collect biomarker information.
- Conditions
- Acute Stress Reaction, Cognitive Performance
- Being tested
- Sparrow Hawk (Active), Sparrow Hawk (Sham)
- Keywords
- Healthy Human, Performance, Stress, Vagus Nerve Stimulation, Neurostimulation, Transcutaneous Auricular Neurostimulation, Military
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow Hawk (Active)Device
Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of active (prophylactic or acute) therapy according to the participant's randomization group.
Sparrow Hawk (Sham)Device
Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of sham (prophylactic or acute) therapy according to the participant's randomization group.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN for Prophylactic Treatment | Experimental | Prophylactic Active participants will undergo 20 minutes of active tAN while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol. Receives: Device: Sparrow Hawk (Active) |
| Sham Stimulation for Prophylactic Treatment | Sham comparator | Prophylactic Sham participants will undergo 20 minutes of sham stimulation while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol. Receives: Device: Sparrow Hawk (Sham) |
| Active tAN for Acute Treatment | Experimental | Acute Active participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, active tAN treatment will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol. Receives: Device: Sparrow Hawk (Active) |
| Sham Stimulation for Acute Treatment | Sham comparator | Acute Sham participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, sham stimulation will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol. Receives: Device: Sparrow Hawk (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Match-to-Sample Task (MST)
Mean change in performance on the MST (in combination with the Psychomotor Vigilance Task (PVT) and Perdue Pegboard Task (PPT)) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The MST assesses short-term spatial memory (working memory) and pattern recognition skills. An 8 × 8 matrix of a red and green checkerboard pattern will be presented for 10 seconds, then removed, and then followed by a variable delay of 8 or 16 seconds. Two matrices will then be presented: the original matrix and a matrix with the color of 2 squares reversed. The subjects will attempt to select the original matrix. The task consists of 30 trials, ≈15 for each delay. A response (left or right arrow key) is required within 10 s, or a time-out error will be recorded. Correct matches were recorded, as was reaction time. This test takes less than 5 minutes to complete.
Measured: From baseline to post-stressor (up to 3 hours)
Psychomotor Vigilance Task (PVT)
Mean change in performance on the PVT (in combination with the MST and PPT) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The PVT is a test of visual reaction time. A series of stimuli are presented at random intervals on a screen, and the subject responds as rapidly as possible when a stimulus appears. Response time, false alarms, and the number of lapses (long duration responses) will be recorded. Performance lapses refer to the instances when a subject failed to respond in <500 ms. This test will be administered on a computer monitor or tablet.
Measured: From baseline to post-stressor (up to 3 hours)
Perdue Pegboard Task (PPT)
Mean change in performance on the PTT (in combination with the PVT and MST) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The PPT is a psychomotor test of manual dexterity and bimanual coordination. A pegboard consisting of two parallel sets of twenty-five holes arranged vertically is presented to the participant, and they are asked to remove pegs from concave cups at the top of the board and place them in the holes sequentially as rapidly as possible. The number of pegs placed successfully in thirty seconds is scored. Each participant is tested three times using both hands.
Measured: From baseline to post-stressor (up to 3 hours)
Maastricht Acute Stress Test (MAST)
The MAST is a safe, non-invasive, and expedited method to create a stress response in human subjects under laboratory conditions. The test combines two well-validated laboratory stress paradigms, the Trier Social Stress Test (TSST) and the Cold Pressor Test (CPT) into a single protocol. The MAST is effective in increasing salivary cortisol, increasing blood pressure, salivary alpha-amylase, and eliciting subjective stress reactions. Participants will be videotaped and monitored to analyze their facial expressions. They will undergo multiple hand immersion trials (HIT) in which they have to immerse their hand in ice-cold (2 °C) water. They will engage in mental arithmetic trials (MAT), counting backwards starting at 2043 in steps of 17 as fast and accurate as possible. For each mistake made, the experimenter will provide negative feedback and instruct them to start over at 2043.
Measured: After baseline tasks, approximately 35 minutes
Secondary outcomes (9)
Mean change in performance on the MST in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Mean change in performance on the MST in combination with PVT and PPT
Measured: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PVT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Mean change in performance on the PVT in combination with MST and PPT
Measured: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PPT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Mean change in performance on the PPT in combination with MST and PVT
Measured: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the MTS in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Mean change in performance on the MST in combination with PVT and PPT
Measured: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PVT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Mean change in performance on the PVT in combination with MST and PPT
Measured: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PPT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Mean change in performance on the PPT in combination with MST and PVT
Measured: From baseline to post-stressor (up to 3 hours)
Change in working memory as measured by performance on the MST
Measured: From baseline to post-stressor (up to 3 hours)
Change in reaction time as measured by performance on the PVT
Measured: From baseline to post-stressor (up to 3 hours)
Change in dexterity as measured by performance on the PPT
Measured: From baseline to post-stressor (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start26 Nov 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomized, double-blind, sham-controlled trial in sixty healthy, able-bodied participants. Participants will be randomized to one of four treatment groups in a 1:1:2:2 ratio. Twice as many participants will be randomized to the acute treatment active tAN and acute treatment sham tAN arms (Groups 3 and 4) compared to the prophylactic treatment group arms (Groups 1 and 2).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Battelle Memorial Institute, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Philip Putnam, PhD, Principal investigator, Battelle Memorial InstituteNavid Khodaparast, PhD, Principal investigator, Spark Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390267
- Sponsor's protocol ID
- SBM-ASR-01
- Acronym
- ASR
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
- ClinicalTrials.gov ID
- NCT06390267
- Acronym / sponsor ID
- ASR / SBM-ASR-01
- Conditions
- Acute Stress Reaction, Cognitive Performance
- Keywords
- Healthy Human, Performance, Stress, Vagus Nerve Stimulation, Neurostimulation, Transcutaneous Auricular Neurostimulation, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Battelle Memorial Institute, United States Department of Defense
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.
Detailed description
This study is designed as a randomized, double-blind, sham-controlled trial. Sixty healthy, able-bodied participants will be randomized 1:1:2:2 into one of four experimental groups:
Group 1: Active tAN for prophylactic treatment prior to acute stress exposure (N=10)
Group 2: Sham stimulation for prophylactic treatment prior to acute stress exposure (N=10)
Group 3: Active tAN for acute treatment during acute stress exposure (N=20)
Group 4: Sham stimulation for acute treatment during acute stress exposure (N=20)
Participants will complete a baseline performance of three tasks. tAN treatment will then be administered prior to or during an acute stress test. Participants will complete the same three tasks preformed at baseline. In addition to the tAN therapy earpiece, subjects will have biosensors attached to them to collect biomarker information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study is designed as a randomized, double-blind, sham-controlled trial in sixty healthy, able-bodied participants. Participants will be randomized to one of four treatment groups in a 1:1:2:2 ratio. Twice as many participants will be randomized to the acute treatment active tAN and acute treatment sham tAN arms (Groups 3 and 4) compared to the prophylactic treatment group arms (Groups 1 and 2).
| Arm | Type | Receives |
|---|---|---|
| Active tAN for Prophylactic Treatment | Experimental | Device: Sparrow Hawk (Active)Prophylactic Active participants will undergo 20 minutes of active tAN while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol. |
| Sham Stimulation for Prophylactic Treatment | Sham comparator | Device: Sparrow Hawk (Sham)Prophylactic Sham participants will undergo 20 minutes of sham stimulation while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol. |
| Active tAN for Acute Treatment | Experimental | Device: Sparrow Hawk (Active)Acute Active participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, active tAN treatment will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol. |
| Sham Stimulation for Acute Treatment | Sham comparator | Device: Sparrow Hawk (Sham)Acute Sham participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, sham stimulation will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18 to 41 years old
- Participant has the cognitive and physical abilities to carry out the study tasks
- Proficient in the English language
- Ability to understand the explanations and instructions given by the study personnel
Key exclusion criteria (13 listed)
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has used any psychological stress-management intervention within the last 4 weeks
- Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
- Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
- Participant is currently using anti-anxiety medications such as Xanax or beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow Hawk (Active)Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of active (prophylactic or acute) therapy according to the participant's randomization group. | Device | Active tAN for Acute Treatment, Active tAN for Prophylactic Treatment |
| Sparrow Hawk (Sham)Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of sham (prophylactic or acute) therapy according to the participant's randomization group. | Device | Sham Stimulation for Acute Treatment, Sham Stimulation for Prophylactic Treatment |
Primary outcome
Match-to-Sample Task (MST)
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the MST (in combination with the Psychomotor Vigilance Task (PVT) and Perdue Pegboard Task (PPT)) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The MST assesses short-term spatial memory (working memory) and pattern recognition skills. An 8 × 8 matrix of a red and green checkerboard pattern will be presented for 10 seconds, then removed, and then followed by a variable delay of 8 or 16 seconds. Two matrices will then be presented: the original matrix and a matrix with the color of 2 squares reversed. The subjects will attempt to select the original matrix. The task consists of 30 trials, ≈15 for each delay. A response (left or right arrow key) is required within 10 s, or a time-out error will be recorded. Correct matches were recorded, as was reaction time. This test takes less than 5 minutes to complete.
Psychomotor Vigilance Task (PVT)
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PVT (in combination with the MST and PPT) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The PVT is a test of visual reaction time. A series of stimuli are presented at random intervals on a screen, and the subject responds as rapidly as possible when a stimulus appears. Response time, false alarms, and the number of lapses (long duration responses) will be recorded. Performance lapses refer to the instances when a subject failed to respond in <500 ms. This test will be administered on a computer monitor or tablet.
Perdue Pegboard Task (PPT)
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PTT (in combination with the PVT and MST) in the active tAN acute treatment group (Group 3) compared to sham acute treatment group (Group 4). The PPT is a psychomotor test of manual dexterity and bimanual coordination. A pegboard consisting of two parallel sets of twenty-five holes arranged vertically is presented to the participant, and they are asked to remove pegs from concave cups at the top of the board and place them in the holes sequentially as rapidly as possible. The number of pegs placed successfully in thirty seconds is scored. Each participant is tested three times using both hands.
Maastricht Acute Stress Test (MAST)
Time frame: After baseline tasks, approximately 35 minutes
The MAST is a safe, non-invasive, and expedited method to create a stress response in human subjects under laboratory conditions. The test combines two well-validated laboratory stress paradigms, the Trier Social Stress Test (TSST) and the Cold Pressor Test (CPT) into a single protocol. The MAST is effective in increasing salivary cortisol, increasing blood pressure, salivary alpha-amylase, and eliciting subjective stress reactions. Participants will be videotaped and monitored to analyze their facial expressions. They will undergo multiple hand immersion trials (HIT) in which they have to immerse their hand in ice-cold (2 °C) water. They will engage in mental arithmetic trials (MAT), counting backwards starting at 2043 in steps of 17 as fast and accurate as possible. For each mistake made, the experimenter will provide negative feedback and instruct them to start over at 2043.
9 secondary outcomes
Mean change in performance on the MST in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PVT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PPT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the MTS in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PVT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Time frame: From baseline to post-stressor (up to 3 hours)
Mean change in performance on the PPT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
Time frame: From baseline to post-stressor (up to 3 hours)
Change in working memory as measured by performance on the MST
Time frame: From baseline to post-stressor (up to 3 hours)
Change in reaction time as measured by performance on the PVT
Time frame: From baseline to post-stressor (up to 3 hours)
Change in dexterity as measured by performance on the PPT
Time frame: From baseline to post-stressor (up to 3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Putnam, PhD principal investigator
Battelle Memorial Institute
Navid Khodaparast, PhD principal investigator
Spark Biomedical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Hawk (Active) in people with Acute Stress Reaction and Cognitive Performance, run by Spark Biomedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Match-to-Sample Task (MST) (time frame: From baseline to post-stressor (up to 3 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.